Biotechnology firm Novavax Inc and its partner Serum Institute of India (SII) on Thursday said they have submitted an application to the World Health Organization for emergency use listing (EUL) of Novavax’s COVID-19 vaccine.
The application to WHO is based on the companies’ previous regulatory submission to the Drugs Controller General of India (DCGI), Novavax Inc said in a statement.
“Today’s submission of our protein-based COVID-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world,” Novavax President and Chief Executive Officer Stanley C Erck said.
It represents another major milestone in Novavax’s transformation into a commercial global vaccine company and reinforces the value of global collaboration and need for multiple approaches to help control the pandemic, he added.
The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies, the statement said.
“In addition to the submission for WHO EUL, SII and Novavax last month completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data,” it added.
Novavax’s COVID-19 vaccine is stored at 2 to 8 degrees Celsius, enabling the use of existing vaccine supply and cold chain channels, the statement said.